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Healthtech
Lead cross-functional programs to deliver medical device manufacturing and operations initiatives on time and on budget. Oversee NPI, validations, capacity expansion, ECOs/CAPAs, regulatory alignment (21 CFR 820, ISO 13485, 510(k)), supplier readiness, and continuous improvement. Serve as program owner between Manufacturing, Quality, Supply Chain, R&D, and Regulatory while mentoring staff and driving operational readiness and audit support.
